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Serving 500+ biopharmaceutical companies globally:

Chubb
Moodys
Dow
Argus Health
Queensland Health
Colorcon
Citi
QuintilesIMS
Chinese Patent Office
Medtronic

Generated: July 25, 2017

DrugPatentWatch Database Preview

Santarus Company Profile

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What is the competitive landscape for SANTARUS, and what generic alternatives to SANTARUS drugs are available?

SANTARUS has six approved drugs.

There are seventeen US patents protecting SANTARUS drugs.

There are one hundred and fifty-four patent family members on SANTARUS drugs in twenty-six countries.

Summary for Applicant: Santarus

Patents:17
Tradenames:4
Ingredients:4
NDAs:6
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 2006ABRXYesNo► Subscribe► Subscribe ► Subscribe
Santarus
ZEGERID
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET, CHEWABLE;ORAL021850-001Mar 24, 2006DISCNNoNo► Subscribe► Subscribe ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004ABRXYesNo► Subscribe► SubscribeYY ► Subscribe
Santarus Inc
GLUMETZA
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL021748-001Jun 3, 2005AB3RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Santarus

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-001Jun 15, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
FOR SUSPENSION;ORAL021636-002Dec 21, 2004► Subscribe► Subscribe
Santarus Inc
ZEGERID
omeprazole; sodium bicarbonate
CAPSULE;ORAL021849-001Feb 27, 2006► Subscribe► Subscribe
Santarus
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
magnesium hydroxide; omeprazole; sodium bicarbonate
TABLET;ORAL022456-001Dec 4, 2009► Subscribe► Subscribe
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Paragraph IV activity for SANTARUS drugs

Drugname Dosage Strength Tradename Submissiondate
fenofibrate
Tablets40 mg and 120 mg
FENOGLIDE
3/17/2010
metformin hydrochloride
Extended-release Tablets500 mg and 1000 mg
GLUMETZA
7/27/2009
omeprazole and sodium bicarbonate
Powder for Oral Suspension20mg/1680mg per packet
ZEGERID
11/13/2007
omeprazole and sodium bicarbonate
Powder for Oral Suspension40 mg/1680 mg per packet
ZEGERID
8/24/2007
omeprazole and sodium bicarbonate
Capsules20 mg/1100 mg and 40 mg/1100 mg
ZEGERID
4/30/2007

Non-Orange Book Patents for Santarus

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,772,273Stabilized atorvastatin► Subscribe
8,128,957Modified release compositions of at least one form of tramadol► Subscribe
8,158,147Modified release formulations of at least one form of tramadol► Subscribe
2,005,182,056► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Santarus Drugs

Country Document Number Estimated Expiration
European Patent Office1818049► Subscribe
Austria340574► Subscribe
Japan2007508248► Subscribe
Cyprus1107512► Subscribe
European Patent Office1430895► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Santarus Drugs

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
496Luxembourg► SubscribePRODUCT NAME: COMBINAISON DE DAPAGLIFLOZINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI ET DE METFORMINE OU D UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELLE-CI,TELLE QUE PROTEGEE PAR LE BREVET DE BASE EP1506211 B1
C0006France► SubscribePRODUCT NAME: PIOGLITAZONE/METFORMINE ET LEURS SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE IN FRANCE: EU/1/06/354/001 DU 20060728; REGISTRATION NO/DATE AT EEC: EU/1/06/354/001 DU 20060728
/2008Austria► SubscribePRODUCT NAME: SITAGLIPTIN, GEGEBENENFALLS IN DER FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE ALS MONOPHOSPHAT, UND METFORMIN, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, INSBESONDERE DES HYDROCHLORIDS; NAT. REGISTRATION NO/DATE: EU/1/08/455/001-014, EU/1/08/456/001-014, EU/1/08/457/001-014 20080716; FIRST REGISTRATION: CH 58450 01-03 20080408
C/GB11/013United Kingdom► SubscribePRODUCT NAME: NAPROXEN AND ESOMEPRAZOLE; REGISTERED: UK PL 17901/0263-0001 20101105
2014026Lithuania► SubscribePRODUCT NAME: DAPAGLIFOZINUM + METFORMINUM; REGISTRATION NO/DATE: EU/1/13/900 20140116
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Similar Applicant Names

Individual applicants are sometimes listed under multiple names.
Here is a list of applicants with similar names.

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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Accenture
McKesson
QuintilesIMS
Deloitte
Moodys
AstraZeneca
Merck
Healthtrust
Cantor Fitzgerald
Medtronic

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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